Diclofenac Sodium Topical Solution Recalled for Manufacturing Compliance Deviations
Teligent Pharma recalled 36,018 bottles of Diclofenac Sodium Topical Solution nationwide due to cGMP deviations related to discontinued stability studies, affecting all batches through May 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The recall stems from manufacturing process deviations (discontinued stability studies) that prevent verification of product quality through expiration.
Plain-English summary
Teligent Pharma, Inc. is recalling all Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. bottles distributed nationwide in the USA and Puerto Rico. The recall affects 36,018 bottles across multiple batches with expiration dates through May 31, 2024.
The recall was issued because the manufacturer discontinued its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation. The firm can no longer verify that the product maintains its quality and safety profile throughout its stated shelf life.
Consumers in possession of affected Diclofenac Sodium Topical Solution should stop using the product and contact their healthcare provider or pharmacist for guidance. Patients taking this medication should not discontinue treatment without medical consultation and should speak with their provider about alternative options.
The recalled product
- Product
- Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical
- Hazard
- cGMP-deviation
- unverified-stability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch: 15384
- Exp. 3/31/2023
- 15646
- Exp. 5/31/2023
- 15971
- Exp. 9/30/2023
- 16206
- 16226
- Exp. 11/30/2023
- 16268
- Exp. 12/31/2023
- 16342
- 16343
- Exp. 1/31/2024
- 16503
- 16504
- Exp. 3/31/2024
- 16632
- Exp. 4/30/2024
- 16715
Distribution
Distributed nationwide across the United States.
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